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510(k) K010114

ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) by Johnson & Johnson Vision Care, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2001
Date Received
January 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Johnson & Johnson Vision Care, Inc.

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  • K200243 — ACUVUE (senofilcon A) Soft Contact Lens Multifocal (March 17, 2020)
  • K180299 — ACUVUE OASYS (senofilcon A) with Photochromic Additive (April 10, 2018)
  • K160212 — ACUVUE (senofilcon C) Soft Contact Lens (March 28, 2016)
  • K141670 — ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA (September 18, 2014)
  • K100349 — VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER (May 21, 2010)
  • K073485 — VISTAKON (NARAFILCON) A SOFT CONTACT LENS (March 3, 2008)
  • K062614 — VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBI (November 1, 2006)
  • K051900 — ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKE (August 12, 2005)
  • K032340 — VISTAKON (GALYFILCON A) SOFT CONTACT LENS (October 16, 2003)

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  • K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (July 30, 2025)
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